DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “...the wire into a ball shape and pressing the wire into the substrate” in claim 3 is failing to comply with the written description requirement. As shown in Fig. 2, at the step 208, the wire creates a ball shape that contacts to a surface of the substrate; however, it does not show that the wire is being pressed into the substrate.
At this point, it is unclear to Examiner that the ball shape is whether located into the substrate (because of pressing into the substrate) or the ball shaped is located/attached (by friction weld) onto the substrate, as shown in #208 & 210 in Fig. 2.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 & 18 recite the limitation "the wire bonding process" in line 4 of claim 1 and in line 5 of claim 18. There is insufficient antecedent basis for this limitation in the claims.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation “a bonder head” is vague. It is unclear to Examiner that which element is being referred to “a bonder head”. Is “bonder head” being designated to a holder of a wire?
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7, 9, 18-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Mohammed (US 2015/0044823).
Regarding claim 1, Mohammed discloses a method of fabricating a microneedle, comprising:
Note: a wire bond 32 formed of metal and has a shape configuration that looks alike “a microneedle”. Therefore, it is fair enough to call the wire bond 32 as “a microneedle”.
applying a force to a conductive wire 74 to create a friction weld at 34 between the wire 74 and a substrate 12, see Figs. 4-5;
extruding the wire 74 (Fig. 6) and interrupting a wire bonding process (Figs. 7-8); and
applying a wire weakening process at a desired microneedle length to cause the wire to break at the desired microneedle length, paras [0038, 0054] & Fig. 9.
Regarding claim 2, wherein applying the force comprises applying a thermosonic process (para [0038]) or applying an ultrasonic vibration (e.g., a wedge-bonding procedure that is formed of wire bonding, para [0036].
Note: wedge-bonding is a microelectronic packaging technique that uses pressure and ultrasonic energy to vibrate the wedge and to join a wire to a bonding pad.
Regarding claim 3, wherein creating the friction weld comprises: electroforming, using a wire bonder, the wire into a ball shape 34 and pressing the wire into the substrate. In addition, a person skilled in the art would recognize that the step of pressing the wire into the substrate for enhancing of attachment in between the wire and the substrate.
Regarding claim 4, as best as understood, wherein applying the wire weakening process comprises: rapidly moving a bonder head 70 of the wire bonder to a return/retract position, as shown in Figs. 8-9.
Regarding claim 5, wherein applying the wire weakening process comprises: applying a weakening force (e.g., plastic deformation of wire 74 in area 78) to cause stress in the wire at the desired microneedle length, para [0052] & Fig. 7-8.
Regarding claim 7, further comprising: breaking the wire at the desired microneedle length to create the microneedle, paras [0038, 0054] & Fig. 9.
Regarding claim 9, Mohammed discloses a microneedle array 10 in Fig. 1 comprising:
a substrate 12 defining a base layer material suitable for a wire bonding process (as shown in Figs. 4-9; and a plurality of solid microneedles 32 (in Fig. 1) provided on the substrate and fabricated in accordance with the method of claim 1, as discussed in the rejection in claim 1 above.
Regarding claim 18, this claim is being rejected using the same analysis as noted above with regard to claim 1. Mohammed further shows in Fig. 1 that a microneedle array 10 comprising: a plurality of microneedles 32. In other words, the method of fabricating the microneedle array for multiple of microneedles 32 would be applied same method of fabricating for each of multiple microneedles.
Regarding claim 19, wherein applying the wire weakening process comprises, for a set of adjacent microneedles in the plurality of microneedles: controlling a path of a wire bonding head to create first and second microneedles in the set of adjacent microneedles, see Fig. 1.
As mentioned in claim 1 above, Mohammed discloses the step of applying a wire weaking process at a desired microneedle length (e.g., the desired length of the wire segment to form the wire bond is drawn out of the bonding tool, which can then cut the wire bond at the desired length, see para [0038]). Therefore, a person skilled in the art would recognize that using the same method as mentioned above, for producing first and second microneedle that have different in desired heights/lengths. In other words, the first microneedle has a first heigh, and the second needles has a second height.
Regarding claim 20, a person skilled in the art would recognize that using the same method of fabricating more than one microneedle with providing conductive wires 74 in different size, thereby a first conductive wire 74 having a first diameter to form a first diameter microneedle; and obtaining a second conductive wire 74 having a second diameter different from the first diameter to form a second diameter microneedle.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mohammed (US 2015/0044823) in view of Persson et al. (US 4,213,556).
Mohammed discloses all the claimed subject matter as required. Mohammed discloses the step of applying the wire weakening process comprises applying a pulling force by pulling the capillary 70, in Figs. 8-9, but does not disclose that the step of pulling force by using an automated programmable wire bonder.
Persson discloses a method of a wire bonder for producing a wire 12 (or bonding a wire 12 to a substrate). The wire 12 has a shape that similar to a needle or microneedle. Therefore, a person skilled in the art would recognize that the method of bonding in between the wire to the substrate in Persson can be applied in Mohammed for bonding the microneedle to the substrate.
Persson discloses the method of applying a force to a conductive wire 12 to create a friction weld in between the wire and a substrate, Fig. 3; extruding the wire 12 and interrupting the wire bonding process by retracting the tip of the capillary 18 by applying a pulling force to apply the wire weakening process, see steps A, B & C in Fig. 4; wherein applying the pulling force using an automated programmed wire bonder, see Fig. 1, col. 2,lines 55-56, col. 4, lines 50-55.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method of applying the wire weakening process in Mohammed with applying a pulling force using an automated programmable wire bonder, as taught by Persson, in order to detect the failure of a lead bond to form a wire tail (or a microneedle tip) at a desired length/height.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mohammed (US 2015/0044823) in view of Arai (US 5,476,357).
Mohammed discloses all the claimed subject matter as required. Mohammed discloses breaking the wire at the desired microneedle length comprising applying the wire weakening process (e.g., constriction wire area at 78). Mohammed does not disclose the method of using a micromanipulator to apply the wire weaking process; however, using a micromanipulator is considered as intended use purpose.
Arai states in the Background of the Invention that it is well-known in the art that a micromanipulator is adapted to use in fields requiring positioning on the micron order
Micromanipulation is the technology of conducting operations on minute objects with sizes on the order of several tens of µm. It can be effectively applied, for instance, for grasping a minute object with two fingers and positioning it by translational and rotational motion, as well as for operations such as gripping, pressing, cutting, stretching, compressing, perforating, mixing and propelling. As such, it has become an indispensable technology in a wide range of fields including biotechnology and medicine. However, since most of the micromanipulators that have become commercially, available up to the present consist of a combination of a mechanism for translational motion in three mutually perpendicular directions and a gripper, they are not optimally adapted for use with microscopic objects, see Description of the Prior art, col. 1, lines 13-27.
Arai also discloses that: when selected links of the hand modules of the so-configured micromanipulator are extended/contracted by operating the associated actuators, the positions and directions of the end-effectors are controlled with six degrees of freedom according to the amount of link contraction, whereby the fingers of the micromanipulator can be caused to execute prescribed motions, col. 2, lines 44-50.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method of breaking the wire in Mohammed with using a micromanipulator to grasp and extend the wire, as taught by Arai, in order to grasp or hold the micro-object, i.e., wire in very small scale in strong/firmly enough without breaking down under external force and able to flow rapid movements with good response.
Claims 9-11, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Fleming et al. (US 6,908,453) in view of Mohammed (US 2015/0044823).
Regarding claim 9, Fleming discloses a microneedle array 410, in Figs. 8-10 comprising:
a substrate 420 defining a base layer material 424 suitable for a wire bonding process; and
a plurality of solid microneedles 430 provided on the substrate and fabricated in accordance with the method of claim 1.
Note: It is noted that the product-by-process limitation “wire bonding process” and “fabricated in accordance with the method in claim 1” has not been given weight in determining the patentability of the device claim. See MEPE §2113. Therefore, these limitations above are considered as functional limitations.
Fleming discloses the plurality of solid microneedles 430 adhere in a friction contact to the base layer material of the substrate 420. Therefore, a person skilled in the art would recognize that providing the solid microneedle 430 (or plurality of solid microneedles) being in a friction weld by the method of fabricating the microneedle, as taught by Mohammed, as discussed in the claim 1 above.
Note: the microneedle 430 in Fleming is in triangle shape; however, a person skilled in the art would recognize that the shape of the microneedle can be produced in elongated needle-shaped, as shown in Figs. 10A-11 and it performs well as the triangle shaped.
Regarding claim 10, Fleming (or Fleming in view of Mohammed) discloses a microneedle array; wherein the substrate 420 comprises a plurality of microfluidic channels 427 each having a channel outlet (one end of the channel 427 is directly in contact/communicate the needle 430, see Figs. 8-10; the channel outlets provided adjacent bases of the plurality of solid microneedles to enable drug delivery.
Regarding claim 11, Fleming (or Fleming in view of Mohammed) discloses further comprising: a control channel 470/428 configured to enable selective activation of a subset of the plurality of solid microneedles, Figs. 8-10.
Regarding claim 16, Fleming (or Fleming in view of Mohammed) discloses that wherein at least some of the plurality of solid microneedles are coated in a bioresorbable compound, i.e., hydrophilic, capable of drug delivery, col. 12, lines 23-32 & claim 5 in Fleming.
Regarding claim 17, Fleming (or Fleming in view of Mohammed) discloses wherein the microneedle array 830 is configured to be affixed to an external system to facilitate one or more of: drug delivery; processing of biosignals 870; and microfluids testing systems, see Fig. 15. Note: the Fig. 15 is different embodiment in Figs. 8-10 in Fleming. A person skilled in the art would recognize that the device in Figs. 8-10 can be provided the biosensor 870 in the device in Figs. 8-10.
Claims 9-15 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yuzhakov et al. (US 6,256,533).
Regarding claim 9, Yuzhakov discloses a microneedle array, in Fig. 24, 27 & 29 comprising:
a substrate 562/563 defining a base layer material; and a plurality of solid microneedles 580/680 provided on the substrate
With regarding the limitations, i.e., ... a wire bonding process & (plurality of solid microneedles) fabricated in accordance with the method of claim 1, are product-by-process limitations in the device claim and has/have not been given weight in determining the patentability of the device claim. See MEPE §2113.
PNG
media_image1.png
616
864
media_image1.png
Greyscale
Regarding claim 10, wherein the substrate 562/563/662 comprises a plurality of microfluidic channels 585/586/685 each having a channel outlet, the channel outlets provided adjacent bases of the plurality of solid microneedles to enable drug delivery, see Figs. 24, 26 & 29.
Regarding claim 11, further comprising: a control channel 585/586/685 (or 560/561/660) configured to enable selective activation of a subset of the plurality of solid microneedles.
Regarding claim 12, wherein: the control channel 585/586/685 is configured to send individually addressable signals to the plurality of solid microneedles to enable electroporation of epidermal cells of a skin surface to increase uptake of a drug, col. 23, lines 10-15 & see Figs. 24, 26-27 & 29.
Regarding claim 13, wherein: the control channel is configured to send individually addressable signals to the plurality of solid microneedles to enable iontophoresis of pharmacological compounds to increase uptake of a drug, see abstract, col. 3, lines 8-13; col. 23, lines 10-15 & see Figs. 24, 26-27 & 29.
Regarding claim 14, further comprising: a controller 720 configured to provide a control signal on the control channel for selective activation of the subset of the plurality of solid microneedles, col. 21, line 41-col. 22, line 33, see Figs. 30-31. Note: the controller 720 is included in the device in Figs. 24, 26-27 & 29.
Regarding claim 15, wherein: the control channel 585/586/685 is configured to receive signals from the plurality of solid microneedles to enable detection of biosignals (from body-fluid sampling sensors), col. 18, lines 38-44
Note: the limitation (electrical activity due to biological interactions with a coating on the plurality of solid microneedles) follows a conjunction “or” does not need to include in the prior art.
Regarding claim 17, wherein the microneedle array is configured to be affixed to an external system (a pump, col. 18, lines 50-51; or #592, 594, 596 in Fig. 27; or #720-722, 730 to facilitate one or more of: drug delivery (via pump, or fluid channel 730); processing of biosignals (via sensor); and microfluids testing systems.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yuzhakov et al. (US 6,256,533) in view of Burton (US 2020/0368512).
Regarding claim 16, Yuzhakov discloses all claimed subject matter except for the limitation that wherein at least some of the plurality of solid microneedles are coated in a bioresorbable compound capable of drug delivery.
Burton discloses a microneedle array 10 comprising: plurality of solid microneedles 18 are coated in a bioresorbable compound (lubricious coating) capable of drug delivery, para [0003].
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Yuzhakov with including a lubricious coating on the solid microneedles, as taught by Burton, in order to ease of puncturing/penetrating the skin.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights